I’ve been working for a few months now on a hobby project, WellPilot, with the goal of turning complex health data into simple guidance for optimal wellbeing. (Probably need to simplify that statement, huh?)
For this hobby, I keep an eye out for useful data sources that can help make WellPilot more accurate and more useful. So I was excited when I read about openFDA, the US Food and Drug Administration’s new initiative to make their data more open and accessible.
The first dataset they’ve launched is for adverse events. An adverse event is, for the most part, a negative side effect. Healthcare professionals and manufacturers report these to the FDA for drugs, supplements and other things people tend to put in their body.
This reporting is important because many side effects aren’t discovered until a large number of patients start using a marketed product. While clinical trials are supposed to be representative of a population taking a drug, they are often too small to capture every meaningful permutation of biology (think, for example, about how genetic variations affect drug metabolism) and too short to fully understand the long-term effects. This is why post-marketing databases such as the FDA’s adverse events database are so important.
Unfortunately, such databases haven’t been easy to tap, especially for hobbyist programmers like me.
With openFDA, that’s all changed. Through a simple application programming interface (API)—basically, enabling online requests that return data in machine-usable format—the FDA has made adverse event information easily accessible.
WellPilot now incorporates this information in three ways:
- A list of all side effects* for treatments we’ve analyzed; see all side effects here
- A list of side effects associated with treatments (example here: caffeine), organized in descending order of FDA reports
- A list of all treatments associated with side effects (example here: nausea), organized in descending order of FDA reports
Some people might wonder why this is useful. After all, many websites offer side effect information—for example, consumer health sites such as WebMD. However, these are often not comprehensive or entirely up to date. For example, the official labels for prescription drugs are based off clinical trials, with limitations noted above. WellPilot side effect data is regularly refreshed based on reports to the FDA.
This is just a start of how WellPilot might use adverse event data—not to mention other data openFDA should have in future. For example, some ideas I’m considering:
- Allowing people to track treatments they’re taking to see of which side effects they’re most at risk overall
- Allowing people to see both how effective a treatment is for a condition, as well as how severe the side effects might be
- Making analysis of condition-treatment relationships smarter by informing the analysis algorithm of what’s a likely side effect (for example, with adverse event data, the algorithm would be more likely to flag “nausea” as a side effect of chemotherapy treatment rather than something chemotherapy treats)
- Evaluating side effect risks of treatments for specific conditions (whereas we currently just evaluate it for treatments overall)
If you have any thoughts, feel free to comment here or reach out to me on Twitter.
* Note: We call them “side effects” on WellPilot rather than “adverse events” because the former is a more consumer-friendly term. In reality, however, some adverse events are not really side effects. They include things like drugs not working at all, or a method of administration not working as intended. But, for the most part, I think the label works, and it’s what consumers are most familiar with.